Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers (TRIPLE 1)

October 28, 2021 updated by: Chiesi Farmaceutici S.p.A.

Open-label, Randomized, Single-dose, Placebo-controlled, 4-way Crossover Study to Investigate the Pharmacokinetic Interaction of Glycopyrrolate and Formoterol in Healthy Subjects.

This study will be carried out in healthy volunteers with the primary objective to evaluate the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised metered dose inhaler (pMDI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Lange Beeldekensstraat 267
      • Antwerpen, Lange Beeldekensstraat 267, Belgium, 2060
        • Clinical Pharmacology Unit - SGS Life Science Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females healthy volunteers aged 18-65 years will be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
placebo pMDI
Experimental: Treatment T
Drug: Glycopyrrolate + Formoterol
glycopyrrolate pMDI + formoterol pMDI
Active Comparator: Treatment R2
Drug: Formoterol
formoterol pMDI
Active Comparator: Treatment R1
Drug: Glycopyrrolate
glycopyrrolate pMDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics: formoterol and glyco AUC0-t
Time Frame: from pre-dose to 32 hours after administration
Area under the plasma concentration curve observed from administration up to the last measurable concentration.
from pre-dose to 32 hours after administration
Pharmacokinetics: formoterol and glyco Cmax
Time Frame: from pre-dose to 32 hours after administration
Maximum plasma concentration
from pre-dose to 32 hours after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional pharmacokinetic variables
Time Frame: from pre-dose to 32 hours post dose
Plasma Glyco AUC0-30min, AUC0-32h, AUC0-inf, tmax and t1/2 - Plasma Formoterol AUC0-30min, AUC0-24h, AUC0-inf, tmax and t1/2.
from pre-dose to 32 hours post dose
Serum potassium
Time Frame: From pre-dose to 24 hours after administration
Serum potassium Cmin, tmin and AUC0-24h
From pre-dose to 24 hours after administration
Plasma glucose
Time Frame: from pre-dose to 24 hours after administration
Plasma glucose Cmax, tmax and AUC0-24h
from pre-dose to 24 hours after administration
Lung function
Time Frame: from pre-dose to 1 hour after administration
FEV1 in order to assess potential occurrence of paradoxical bronchospasm
from pre-dose to 1 hour after administration
Vital signs
Time Frame: from pre-dose to 24 hours after administration
heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP).
from pre-dose to 24 hours after administration
ECG
Time Frame: from pre-dose to 24 hours after administration
12-lead ECG parameters: HR, RR, PR, QRS, QT, QTcB, QTcF
from pre-dose to 24 hours after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

  • Principal Investigator: Lien Gheyle, MD, Clinical Pharmacology Unit at SGS Life Sciences - Antwerpen (Belgium)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 9, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimate)

July 20, 2011

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-1101-PR-0056
  • 2011-001552-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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